Lymphoma
Conditions
Keywords
recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma
Brief summary
RATIONALE: Vaccines made from a person's cancer cells may make the body build an effective immune response to kill cancer cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood and may stimulate the immune system in different ways and stop cancer cells from growing. PURPOSE: This phase II trial is studying how well giving vaccine therapy together with GM-CSF works in treating patients with progressive B-cell non-Hodgkin's lymphoma.
Detailed description
OBJECTIVES: Primary * Provide treatment with autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId)™ and sargramostim (GM-CSF) to patients with progressive grade 1, 2, or 3 follicular B-cell non-Hodgkin's lymphoma who did not receive FavId™ while enrolled on protocol FAV-ID-06. Secondary * Determine the response rate and duration of response in patients treated with this regimen. * Determine the response rate and response rate improvement after best response to prior salvage therapy in patients treated with this regimen. * Determine the time to progression in patients treated with this regimen. * Determine the safety of this regimen in these patients. OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 groups according to timing of disease progression while enrolled on protocol FAV-ID-06 (disease progression after prior rituximab AND never randomized vs disease progression after randomization to placebo arm). Patients receive autologous immunoglobulin idiotype-KLH vaccine subcutaneously (SC) on day 1. Patients also receive sargramostim (GM-CSF) SC on days 1-4. Treatment repeats monthly for 6 months in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may receive additional treatment as above every 2 months for 1 year (6 treatments) and every 3 months until disease progression. After completion of study treatment, patients are followed for 30 days or until the start of subsequent treatment. PROJECTED ACCRUAL: Approximately 238 patients (67 in group I and 171 in group II) will be accrued for this study.
Interventions
BIOLOGICALsargramostim
Sponsors
National Cancer Institute (NCI)
Favrille
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed follicular B-cell non-Hodgkin's lymphoma (NHL) * Grade 1, 2, or 3 * Progressive disease AND did not receive autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId™) while enrolled on protocol FAV-ID-06 * Meets 1 of the following criteria: * Received salvage therapy after completion of protocol FAV-ID-06 * At least 4 weeks, but no more than 4 months, since prior salvage therapy * Did not receive salvage therapy after completion of protocol FAV-ID-06 * At least 4 weeks, but no more than 4 months, since completion of prior treatment on protocol FAV-ID-06 * No history of CNS lymphoma OR meningeal lymphomatosis PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Cardiovascular * No history of congestive heart failure Pulmonary * No history of compromised pulmonary function Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No active bacterial, viral, or fungal infection * No psychiatric disorder * No other serious nonmalignant disease that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * No prior allogeneic transplantation\* * No prior rituximab regimen\* other than that administered on protocol FAV-ID-06 (rituximab 375 mg/m\^2 IV weekly for 4 weeks) Chemotherapy * No prior purine analogues\* (e.g., fludarabine or cladribine) Endocrine therapy * No prior or concurrent steroids (e.g., steroid doses in excess of daily replacement) Radiotherapy * Not specified Surgery * Not specified Other * Recovered from prior salvage therapy * No prior or concurrent immunosuppressive therapy * No prior investigational agents\* * No other concurrent antilymphoma therapy NOTE: \*As salvage therapy administered between completion of protocol FAV-ID-06 and enrollment onto this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId)™ provided to patients who did not receive autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId)™ during participation on study Favld-06 | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate by modified Cheson Criteria | — |
| Duration of response by modified Cheson Criteria | — |
| Time to progression | — |
| Response rate improvement | — |
Countries
United States
Outcome results
None listed